On Focus

Author: Giorgio Aime

Intellectual Property and Information Technology

New Medical Devices Regulation’s entry into force to be postponed by one year due to the Covid-19 pandemic

With an urgent procedure, on April 17th 2020, The European Parliament has adopted (693 votes to 1 and 2 abstentions) a Commission’s proposal to postpone new EU rules on medical devices by one year, to ensure legal certainty and the smooth functioning of the internal market amid the Covid-19 pandemic.

As we all know, in 2017 the European Union adopted two separate regulations, specifically aimed at providing a new regulatory framework respectively for medical devices (EU Regulation 745/2017 – the Medical Devices Regulation “MDR”) and in vitro diagnostic medical devices (EU Regulation 746/2017), as new rules were deemed necessary in order to improve patient safety and increase transparency on medical devices across the Union. The new regulations for medical devices and in vitro diagnostic medical devices were supposed to be fully applicable, respectively, on May 26th, 2020 and May 26th, 2022.

However, current developments of the Covid-19 pandemic, as well as the associated increasing need for Member States, health institutions and economic operators to prioritize the fight against the Covid-19 are highly likely to determine the impossibility to ensure proper implementation and application of EU MDR starting May 26th 2020.

The European Commission decided to take action and address the issue adopting, on April 3rd 2020, a proposal (EU Commission proposal COM2020 144 FINAL, full text available here) to amend the EU Medical Devices Regulation, postponing by one year (i.e. until May 26th 2021) its application term. In order to safeguard the presence of a functioning regulatory framework on medical devices until May 26th 2021, the proposal also provides for the delay, to the same extent, of the repeal date of Directives 90/385/EEC and 93/42/EEC.

In addition to the mere deferral of the MDR application terms, with its proposal the European Commission addressed a second issue brought to its attention by the Covid-19 outbreak and currently not duly regulated by the Medical Devices Regulation: the need to timely address potential shortages of vitally important medical devices. To this end, by way of amendment of current art. 59 of the MDR, the proposal sets forth the power for Member States to authorize, in the interest of public health or patient safety and upon duly justified request, the placing on the market (or putting into service) of a specific device for which the applicable procedures have not been carried out. The provision also includes the power for the European Commission, in exceptional circumstances, and for a limited period of time, to extend the EU Member States’ decision to the entire EU market.  This provision could be key to provide a prompt response to shortages of medical devices during pandemics or national emergencies.  

The proposal has now been adopted by the European Parliament and, before its entry into force, it shall be subject to final approval by the Member States and publication in the Official Journal. According to the European Parliament press release, this is expected at the latest by May 26th 2020.

For sake of completion, no risks of delay is currently foreseen nor accounted for by the European Commission in relation to the application of the In Vitro Diagnostics Medical Devices Regulation (EU Regulation 746/2017), the entry into force of which – May 26th, 2022 – is therefore not affected by the newly adopted proposal.